MAUDE Adverse Event Report: MICROVENTION INC. FRED X21; INTRALUMINAL DEVICES

Model Number	FREDX2518-PMA
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: a search for non conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.Complaint system review: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.Ifu review additional information can be found in the ifu potential complications.Below is a list of the probable adverse effects e.G.Complications associated with the use of neurovascular flow diverting stents.Allergic reaction, including but not limited to: contrast dye, nitinol metal, and any other medications used during the procedure.Amaurosis fugax or transient blindness.Aphasia, blindness, cardiac arrhythmia, complications of arterial puncture including pain, local bleeding, or injury to the artery, or adjacent nerves, cranial neuropathy, death, device fracture, migration or misplacement, diplopia, dissection or perforation of the parent artery, headache, hemiplegia, hemorrhage, including intracranial hemorrhage ich, subarachnoid hemorrhage sah, and retroperitoneal, hydrocephalus, infection, mass effect, myocardial infarction, neurological deficits, pseudoaneurysm formation, reactions to anti-platelet or anti-coagulant agents, reactions due to radiation exposure, including alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia.Reactions to anesthesia and related procedures, reactions to contrast agents including allergic reactions and kidney failure , reduced visual acuity or visual field, retinal artery occlusion or infarction, retinal ischemia, rupture or perforation of the aneurysm, stenosis of stented segment, seizure, stent thrombosis, stroke or tia transient ischemic attack, thromboembolic event, vasospasm, visual impairment.I.Directions for use: 26.Note: a slow, proper push/pull technique, encompassing sufficient delivery wire push force, in addition to an opposing microcatheter withdrawal force, to remove excess microcatheter slack while maintaining the microcatheter tip within the center of the parent vessel, will facilitate properly deploying the fred system at the proper location, to achieve full expansion and good vessel apposition.27.Caution: using a rapid microcatheter withdrawal technique to deploy the fred system is not recommended and may result in device elongation or improper deployment.Be aware of delivery wire tip position during deployment.28.If the fred system positioning is not satisfactory, the implant may be recaptured and repositioned if it is not fully deployed.The implant may be recaptured up to 75 percent of its deployed length.29.Caution: if resistance is felt while recapturing the device, do not continue to recapture.Withdraw the microcatheter slightly to unsheath the device without exceeding the recapture limit, and then attempt to recapture again.30.Caution: the fred system must not be re-deployed more than three times.31.If fred system positioning is satisfactory, carefully advance the delivery wire while retracting the microcatheter as needed to minimize slack, maintaining the microcatheter around the center of the parent vessel, to allow the implant to deploy across the neck of the aneurysm.Ensure the implant proximal radiopaque end markers are in the advised position see step 23 proximal to the aneurysm neck for adequate coverage.32.Note: the fred system will expand and may foreshorten up to 60 percent from its undeployed length.Visually verify opening of the proximal end, ensuring that the microcatheter distal tip marker is pulled back, adequately away from the implant proximal end, to allow the proximal end to freely open.Push forward on the delivery wire to assist in maintaining access within the implant as needed.33.Note: visualize and refer to implant radiopaque end markers to maintain adequate implant length on each side of the aneurysm neck/target location to ensure appropriate coverage.34.Warning: do not fully deploy the fred system if positioning in the parent vessel is not satisfactory.35.If necessary, to maintain access through the implanted device, advance the microcatheter distal to the implanted device.Remove and discard the delivery wire.36.Caution: the fred system delivery wire should not be utilized as a guidewire.Do not torque the fred system.A torque device should not be used.37.Carefully inspect the deployed fred implant under fluoroscopy to confirm that it is completely open and opposed to the vessel wall and not kinked.If the implant is not fully open and apposed or is kinked, consider utilizing a suitable micro guidewire and/or occlusion balloon catheter to fully open the implant.38.After completing the procedure, withdraw and discard all applicable accessory devices.Caution: carefully watch the fred implant distal and proximal markers when passing through the implanted device with other devices to avoid displacing the implant.
Event or Problem Description
It was reported that after deploying the flow diverter, physician experienced a lot of resistance pulling the pusher wire out of the headway.It was thought that the pusher wire bumper became stuck on the proximal finished ends of the flow diverter.Ultimately, the sofia was brought all the way up, to pull everything into the sofia.This took a few attempts, and ultimately freed the wire from the flow diverter.A transform balloon was inflated for a few minutes and the bleeding stopped.The flow diverter didn¿t move and still covered the aneurysm.No reported injury to the patient.The patient was reported as ok after waking up.
Additional Manufacturer Narrative
Items returned: n/a visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: a search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.Complaint system review: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.Ifu review (additional information can be found in the ifu): potential complications below is a list of the probable adverse effects (e.G., complications) associated with the use of neurovascular flow diverting stents.Allergic reaction, including but not limited to: contrast dye, nitinol metal, and any other medications used during the procedure amaurosis fugax or transient blindness aphasia blindness cardiac arrhythmia complications of arterial puncture including pain, local bleeding, or injury to the artery, or adjacent nerves cranial neuropathy death device fracture, migration or misplacement diplopia dissection or perforation of the parent artery headache hemiplegia hemorrhage, including intracranial hemorrhage (ich), subarachnoid hemorrhage (sah), and retroperitoneal hydrocephalus infection mass effect myocardial infarction neurological deficits pseudoaneurysm formation reactions to anti-platelet or anti-coagulant agents reactions due to radiation exposure, including alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia.Reactions to anesthesia and related procedures reactions to contrast agents including allergic reactions and kidney failure reduced visual acuity or visual field retinal artery occlusion or infarction retinal ischemia rupture or perforation of the aneurysm stenosis of stented segment seizure stent thrombosis stroke or tia (transient ischemic attack) thromboembolic event vasospasm visual impairment directions for use 26.Note: a slow, proper push/pull technique, encompassing sufficient delivery wire push force, in addition to an opposing microcatheter withdrawal force, to remove excess microcatheter slack while maintaining the microcatheter tip within the center of the parent vessel, will facilitate properly deploying the fred system at the proper location, to achieve full expansion and good vessel apposition.27.Caution: using a rapid microcatheter withdrawal technique to deploy the fred system is not recommended and may result in device elongation or improper deployment.Be aware of delivery wire tip position during deployment.28.If the fred system positioning is not satisfactory, the implant may be recaptured and repositioned if it is not fully deployed.The implant may be recaptured up to 75% of its deployed length.29.Caution: if resistance is felt while recapturing the device, do not continue to recapture.Withdraw the microcatheter slightly to unsheath the device (without exceeding the recapture limit), and then attempt to recapture again.30.Caution: the fred system must not be re-deployed more than three times.31.If fred system positioning is satisfactory, carefully advance the delivery wire while retracting the microcatheter as needed to minimize slack, maintaining the microcatheter around the center of the parent vessel, to allow the implant to deploy across the neck of the aneurysm.Ensure the implant proximal radiopaque end markers are in the advised position (see step 23) proximal to the aneurysm neck for adequate coverage.32.Note: the fred system will expand and may foreshorten up to 60% from its undeployed length.Visually verify opening of the proximal end, ensuring that the microcatheter distal tip marker is pulled back, adequately away from the implant proximal end, to allow the proximal end to freely open.Push forward on the delivery wire to assist in maintaining access within the implant as needed.33.Note: visualize and refer to implant radiopaque end markers to maintain adequate implant length on each side of the aneurysm neck/target location to ensure appropriate coverage.34.Warning: do not fully deploy the fred system if positioning in the parent vessel is not satisfactory.35.If necessary, to maintain access through the implanted device, advance the microcatheter distal to the implanted device.Remove and discard the delivery wire.36.Caution: the fred system delivery wire should not be utilized as a guidewire.Do not torque the fred system.A torque device should not be used.37.Carefully inspect the deployed fred implant under fluoroscopy to confirm that it is completely open and opposed to the vessel wall and not kinked.If the implant is not fully open and apposed or is kinked, consider utilizing a suitable micro guidewire and/or occlusion balloon catheter to fully open the implant.38.After completing the procedure, withdraw and discard all applicable accessory devices.Caution: carefully watch the fred implant distal and proximal markers when passing through the implanted device with other devices to avoid displacing the implant.
Event or Problem Description
It was reported that after deploying the fred x 2.5 x 18mm, physician experienced a lot of resistance pulling the pusher wire out of the headway 21.She thinks that the pusher wire bumper became stuck on the the proximal finished ends of the flow diverter.She ultimately brought the sofia all the way up, to pull everything into the sofia.This took a few attempts, and ultimately freed the wire from the fred.Transform balloon inflated for a few minutes.Bleeding stopped.The patient was ok after waking up.The fred x didn¿t move and still covered the aneurysm.

• Brand Name: FRED X21
• Common Device Name: INTRALUMINAL DEVICES
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16487143
• Report Number: 2032493-2023-00600
• Device Sequence Number: 5899448
• Product Code: OUT
• UDI-Device Identifier: 00842429114223
• UDI-Public: (01)00842429114223(11)210524(17)240430(10)0000145810
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: FREDX2518-PMA
• Device Catalogue Number: FREDX2518
• Device Lot Number: 0000145810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown